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Recent amendments to the reimbursement regime for (generic) medicinal products

Several provisions of the Law of 14 July 1994 on mandatory healthcare and indemnities insurance ("the Law") have recently been amended by the legislator1. Both the regime for the inscription as reimbursable products and the regime of price revision for reimbursable products2 have been amended.

The intention of the Belgian legislator is to address the issue of medicinal products’ availability by guaranteeing the sound functioning of the reference reimbursement system. The former regime provided that the applicant for reimbursement had to make the product available on the market within the three months following the entry into force of the reimbursement decision. The basic rule under the new regime provides that the product must be available on the date of entry into force of the reimbursement decision. However, a new paragraph is inserted, which provides that, where the applicant cannot comply with the obligation to make the product immediately available, it must warn the competent authority in relation to Healthcare Insurance (RIZIV/INAMI), which then registers the product on a list for a maximum of one year, without prejudice to the reimbursement decision. If the product is still unavailable on the first day of the twelfth month following the entry into force of the reimbursement, the product is deleted from the list.

The law provides examples of causes of unavailability but these are not exhaustive. Unavailability may result from the registration suspension, from force majeure or from the existence of a dispute concerning the right to commercialise a product where the main active substance is supposedly protected by a patent. In such circumstances, the product is by right reinserted in the list as from the end of the unavailability. The law does not indicate any maximum duration of such suspension, which means it cannot be precluded that the suspension could last longer than twelve months. It has to be noted that the Belgian legislator chose a progenerics approach.

The preparatory documents of the amending statute also state that the explicit wording of the “Euro-Bolar” provision, as far as its applicability to the price-fixing and reimbursement procedure is concerned, has been considered as unnecessary, given that the current regulatory framework does not prohibit the preparation and introduction of applications for price-fixing and reimbursement before the patent expiry date.

The impact of the amendment to the Law on case law is important to consider. Under the previous regime, the Belgian courts admitted that the imminence of the entry of the newly reimbursable product on the market justified a summary procedure, the urgent character of the matter being sufficiently established. As a consequence of the new regime, the urgent character of the action will be more difficult to demonstrate.